HFNC During Bronchoscopy for Bronchoalveolar Lavage

December 2, 2020 updated by: Federico Longhini, University Magna Graecia

High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage

The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia.

Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography).

Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with Acute Respiratory Failure may sometimes require a bronchial endoscopy for broncho-alveolar lavage (BAL).

During the procedure, hypoxemia may worsen and oxygen may be require to avoid desaturation.

In the recent years, High-Flow through Nasal Cannula (HFNC) has been introduced in the clinical practice. HFNC delivers to the patient heated humidified air-oxygen mixture, with an inspiratory fraction of oxygen (FiO2) ranging from 21 to 100% and a flow up to 60 L/min through a large bore nasal cannula.

HFNC has some potential advantages. First of all, HFNC provides heated (37°C) and humidified (44 mg/L) air-oxygen admixture to the patient, which avoids injuries to ciliary motion, reduces the inflammatory responses associated to dry and cold gases, epithelial cell cilia damage, and airway water loss, and keeps unmodified the water content of the bronchial secretions. Second, HFNC determines a wash out from carbon dioxide of the pharyngeal dead space. Third, HFNC generates small amount (up to 8 cmH2O) of pharyngeal pressure during expiration, which drops to zero during inspiration. Fourth, HFNC guarantees a more stable FiO2, as compared to conventional oxygen therapy. Whenever the inspiratory peak flow of a patient exceeds the flow provided by a Venturi mask, the patient inhaled also part of atmospheric air.

Electrical impedance tomography (EIT) is a noninvasive imaging technique providing instantaneous monitoring of variations in overall lung volume and regional distribution of ventilation, as determined by variations over time in intrathoracic impedance, which is increased by air and reduced by fluids and cells. EIT allows determining changes in end-expiratory lung impedance (EELI), a surrogate estimate of end-expiratory lung volume, assessing global and regional distribution of Vt, and obtaining indexes of spatial distribution of ventilation.

Diaphragm ultrasound is a bedside, radiation free technique to assess the contractility of the diaphragm and the respiratory effort.

In this study investigators aim to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula in terms of respiratory effort (as assessed through diaphragm ultrasound), lung aeration and ventilation distribution (as assessed with EIT) and arterial blood gases.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy
        • AOU Mater Domini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • need for bronchial endoscopy for bronchoalveolar lavage

Exclusion Criteria:

  • life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
  • need for invasive or non invasive ventilation
  • presence of pneumothorax or pulmonary enphisema or bullae
  • recent (within 1 week) thoracic surgery
  • presence of chest burns
  • presence of tracheostomy
  • pregnancy
  • nasal or nasopharyngeal diseases
  • dementia
  • lack of consent or its withdrawal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High Flow Nasal Cannula
High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min.
Device: High Flow Nasal Cannula
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
ACTIVE_COMPARATOR: Conventional Oxygen Therapy
Conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute
Device: Conventional Oxygen Therapy
Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gases at end of the procedure
Time Frame: After 0 minute from the end of the bronchial endoscopy
Arterial blood will be sample for gas analysis
After 0 minute from the end of the bronchial endoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory effort at end of the procedure
Time Frame: After 0 minute from the end of the bronchial endoscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
After 0 minute from the end of the bronchial endoscopy
Respiratory effort at baseline
Time Frame: After 0 minute from enrollment
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
After 0 minute from enrollment
Respiratory effort at the beginning of the bronchoscopy
Time Frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after bronchoscopy
Time Frame: After 10 minute from the end of the bronchial endoscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
After 10 minute from the end of the bronchial endoscopy
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy
Time Frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
Time Frame: After 0 minute from the end of the bronchial endoscopy, compared to baseline
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
After 0 minute from the end of the bronchial endoscopy, compared to baseline
Change of end-expiratory lung impedance (dEELI) from baseline after bronchoscopy
Time Frame: After 10 minute from the end of the bronchial endoscopy, compared to baseline
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
After 10 minute from the end of the bronchial endoscopy, compared to baseline
Change of tidal volume in percentage (dVt%) from baseline at the beginning of bronchoscopy
Time Frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline
Change of tidal volume in percentage (dVt%) from baseline at end of the procedure
Time Frame: After 0 minute from the end of the bronchial endoscopy, compared to baseline
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
After 0 minute from the end of the bronchial endoscopy, compared to baseline
Change of tidal volume in percentage (dVt%) from baseline after bronchoscopy
Time Frame: After 10 minute from the end of the bronchial endoscopy, compared to baseline
change from baseline, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography
After 10 minute from the end of the bronchial endoscopy, compared to baseline
Arterial blood gases at baseline
Time Frame: After 0 minute from enrollment
Arterial blood will be sample for gas analysis
After 0 minute from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2019

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (ACTUAL)

July 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNC-FBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author

IPD Sharing Time Frame

The data will be shared after results publication of indexed journal in english language

IPD Sharing Access Criteria

On reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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